Module232025

12/05/2025

Age Groups

Group

Age

• The full paediatric age range should be covered unless otherwise justified, • Justify ages relevant to disease of interest • Eg puberty (auto-immune diseases) • Maximum ability to reverse burden of disease (eg congenital seizure syndrome) •  Potential Partial waiver

(EU only) Pre-term newborn 0-27 days Term newborn 28 days- 23 months Infants and toddlers 2-11 years Children EU: 12-18 US: 12-<17 Adolescents

The Organisation for Professionals in Regulatory Affairs

5

Paediatric Pharmacokinetics

The Organisation for Professionals in Regulatory Affairs

6